This relates to a medical device and more particularly to a needle control device to obviate or mitigate exposure of excessive radiation to the hand of a user.
Several medical treatments involve the use of needles and continuous applied doses of radiation while a medical practitioner is within the range of the radiation. An example of such a procedure is vertebroplasty.
Percutaneous vertebroplasty involves the injection of a bone cement or other suitable biomaterial into a vertebral body via a percutaneous route under X-ray guidance. The cement is injected as a semi-liquid substance through a needle that has been passed into the vertebral body, generally along a transpedicular or posterolateral approach.
Percutaneous vertebroplasty is intended to provide structural reinforcement of a vertebral body through injection, by a minimally invasive percutaneous approach, of bone cement into the vertebral body. See, for example, Cotten, A., et al xe2x80x9cPercutaneous vertebroplasty: State of the Art.xe2x80x9d Radiographics 1998 March-April; 18(2):311-20; discussion at 320-3. Percutaneous vertebroplasty can result in increased structural integrity, decreased micromotion at the fracture site and possibly a destruction of pain fibers due to the heat of the bone cement as it polymerizes and sets. Complete pain relief can be achieved in up to 80% of patients.
Generally, when performing vertebroplasty, a needle of an appropriate gauge (such as 11 gauge or 13 gauge in a smaller vertebral body) is passed down the pedicle until it enters the vertebral body and reaches the junction of the anterior and middle thirds. Great skill is usually required to insert the needle at a suitable angle and pass the needle through the periosteum, down the pedicle and into the vertebral body. A suitable cement is prepared and injected through the needle and into the vertebral body, under lateral X-ray projection fluoroscopy imaging. The injection is stopped as the cement starts to extend into some unwanted location such as the disc space or towards the posterior quarter of the vertebral body, where the risk of epidural venous filing and hence spinal cord compression is greatest. The injection is also discontinued if adequate vertebral filling is achieved.
The procedure usually requires the user (typically a physician) to hold the needle in position while (at least a portion of) the body is being radiated. This is normally needed since the needle should be stabilized and oriented in the correct position in order for the intended target in the body to be reached. This protocol leads to the creation of a field of radiation within which the user""s hands typically are placed. Consequently, the user will received repeated doses of radiation which can lead to one or more occupational health hazards (e.g., health problems) and/or can shorten the career of the user due to the user receiving quantities of radiation beyond the allowable limits.
Accordingly, there is a need in the art for a means by which radiative medical procedures such as percutaneous vertebroplasty may be performed while obviating or mitigation the deleterious effects of exposure of the physician or other user to excessive radiation.
It is an object of the present invention to provide a novel needle control device for holding a needle that obviates or mitigates at least one of the disadvantages of the prior art.
Accordingly, in one of its aspects, the present invention provides an apparatus for control of a needle (i.e., a needle control device) used in a field of radiation, the apparatus comprising:
a needle collar for attachment to the needle, the needle collar comprising a first attachment point; and
as control bar having a second attachment point, the first attachment point and the second attachment point cooperating to releasably engage the needle collar and the control bar.
In another of its aspects, the present invention provides a needle comprising:
a handle;
a cannula attached to the handle;
a needle collar attached to the needle, the needle collar comprising a first attachment point; and
a control bar having a second attachment point, the first attachment point and the second attachment point cooperating to releasably engage the needle collar and the control bar.
In yet another of its aspects, the present invention provides a kit of parts comprising:
a needle comprising: a handle; a cannula attached to the handle; a needle collar attached to the needle, the needle collar comprising a first attachment point; and
a control bar having a second attachment point, the first attachment point and the second attachment point cooperating to releasably engage the needle collar and the control bar.
Thus, the present invention is an apparatus for a physician to safely hold a needle, during exposure of the treatment site and the needle to radiation, such as X-ray radiation. The apparatus includes a needle collar and a control bar. The needle collar attaches to the needle and has a first attachment point. The control bar has a second attachment point. The first attachment point and the second attachment point cooperate to releasably engage the needle collar and the control bar. In use, the needle collar and the control bar are engaged and the user grasps the control bar to control the needle are engaged and the user grasps the control bar to control the needle while maintaining the hands of the user outside of a field of the radiation, e.g., outside of a field of the X-ray radiation. The control bar is dimensioned such that its proximal end (i.e., the end to be grasped by the user) is outside of the field of radiation.